[Translation] Phase I study on the safety, tolerability, and pharmacokinetics of WG1025 for the treatment of malnutrition epidermolysis bullosa (DEB) and a randomized, double-blind, placebo-controlled Phase II clinical study and extension study
I期:
主要研究目的
评估WG1025在营养不良型大疱性表皮松解症(DEB)治疗中的安全性和耐受性。
次要研究目的
评估WG1025在DEB治疗中的初步有效性。
评价WG1025药代动力学。
评价WG1025的免疫原性。
在DEB患者中,治疗前后COL7A1的表达。
II期
主要研究目的
评估WG1025在DEB治疗中的有效性。
次要研究目的
评估WG1025在DEB治疗中的有效性。
评估WG1025在DEB治疗中的安全性。
评价WG1025药代动力学。
评估WG1025在DEB患者中的免疫原性。
在DEB患者中,治疗前后COL7A1的表达。
拓展期研究目的
评估WG1025在DEB长期治疗中的安全性。
[Translation] Phase I:
Primary study objectives
To evaluate the safety and tolerability of WG1025 in the treatment of dystrophic epidermolysis bullosa (DEB).
Secondary study objectives
To evaluate the preliminary efficacy of WG1025 in the treatment of DEB.
To evaluate the pharmacokinetics of WG1025.
To evaluate the immunogenicity of WG1025.
In DEB patients, the expression of COL7A1 before and after treatment.
Phase II
Primary study objectives
To evaluate the efficacy of WG1025 in the treatment of DEB.
Secondary study objectives
To evaluate the efficacy of WG1025 in the treatment of DEB.
To evaluate the safety of WG1025 in the treatment of DEB.
To evaluate the pharmacokinetics of WG1025.
To evaluate the immunogenicity of WG1025 in DEB patients.
In DEB patients, the expression of COL7A1 before and after treatment.
Extension phase study objectives
To evaluate the safety of WG1025 in the long-term treatment of DEB.